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Pharmaranks rates Rowasa 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Rowasa (Mesalamine) is an aminosalicylate used to treat Ulcerative Colitis, Proctitis, Sigmoid Diseases.

Mesalamine · by Meda Pharms

Available as a generic: Mesalamine

70/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 20, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass
Lower-cost optionsSave up to 78%
This medication~$26.72/30
Cheapest in class · azulfidine en-tabs~$5.92/30
See FDA-approved alternatives

Key facts

Active ingredient
Mesalamine
Drug class
Aminosalicylate
Form
Suspension
Strength
Mesalamine 500MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
Type
Prescription (Rx)
Brand or generic
Brand-name
Manufacturer
Meda Pharms
Half-life
about 7 to 9 hours (apparent terminal half-life) (how long it stays in your system)
What the pharmacy pays
~$26.72 for 30 — not your price
FDA application
NDA019919
Availability
Discontinued (per FDA)

How long does Mesalamine stay in your body?

The elimination half-life of mesalamine is about 7 to 9 hours (apparent terminal half-life) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the apparent TERMINAL (elimination) half-life of mesalamine (5-ASA) itself, from the delayed-release tablet label after 2.4 g and 4.8 g doses; the per-dose table gives terminal-phase means of 8.56 h (1.2 g), 7.05 h (2.4 g) and 7.25 h (4.8 g), with very large between-person variability (standard deviations of 5-8 hours). Metabolite: the label reports the apparent terminal half-life of the major metabolite, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), as 8 to 12 hours — longer than the parent. Mesalamine suppository labels describe N-Ac-5-ASA as "the active metabolite," so the active material can persist somewhat longer than the parent figure alone suggests. Timing caveat: these are delayed-release oral products designed to release drug in the terminal ileum and colon, so absorption is slow and highly variable (median Tmax ~9-24 h depending on product, longer with a high-fat meal) — plasma drug can still be rising many hours after the dose, and the half-life alone does not describe how long drug is present. Older adults: increased age slows apparent elimination — terminal half-life averaged 5.68 h in subjects 18-35 vs 9.68 h at 65-75 and 8.67 h at 75+, with roughly 2-fold higher Cmax. Kidney impairment: the label states systemic exposure is inversely correlated with renal function (lower creatinine clearance, higher exposure); mesalamine is cleared mainly by the kidney as N-Ac-5-ASA. Liver impairment: this label does not state a hepatic-impairment half-life. Mesalamine is not a prodrug (it is the active moiety; sulfasalazine and balsalazide are prodrugs of it). Not a drug-test detection window and not dosing guidance.

This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Mesalamine delayed-release tablets — FDA label, 12.3 Pharmacokinetics (DailyMed, Camber Pharmaceuticals, eff. 2024-02-15).

Drug class

How this class works, per Mesalamine (USAN) - StatPearls - NCBI Bookshelf.

May treat (source: NIH RxClass)

See how Rowasa ranks — best-rated aminosalicylate for:

Dosage forms

Suspension

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

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Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

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Frequently asked questions

What does Rowasa treat?
Rowasa (Mesalamine) may be used to treat ulcerative colitis, proctitis, sigmoid diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How does Rowasa work?
Rowasa is a aminosalicylate. Aminosalicylates (5-ASA drugs like mesalamine) act directly on the inflamed lining of the colon, where they are thought to calm the local inflammatory response by blocking several inflammation-driving chemicals and mopping up tissue-damaging free radicals, which helps the gut heal in ulcerative colitis.
How is Rowasa rated?
pharmaranks gives Rowasa a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
How much does Rowasa cost?
Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $26.72 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Azulfidine En-Tabs — about $5.92 on the same basis.
Is there a coupon or discount for Rowasa?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Rowasa. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Rowasa?
Rowasa is marketed by Meda Pharms. You can see Meda Pharms's full profile, rating, and other products on pharmaranks.
Is Rowasa a brand-name or generic drug?
Rowasa is a brand-name product with the active ingredient Mesalamine. Lower-cost generic equivalents containing Mesalamine are available — ask your pharmacist.
Is Rowasa available over the counter?
No. Rowasa is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Rowasa come in?
Rowasa is currently marketed as suspension, per the FDA's National Drug Code Directory.
What class of drug is Rowasa?
Rowasa is classified as aminosalicylate, per the FDA's Established Pharmacologic Class.
Is Rowasa FDA-registered?
Rowasa is on record with the U.S. FDA under application number NDA019919. You can verify this on its official FDA label.
Has Rowasa been recalled by the FDA?
Rowasa has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Rowasa safe?
There's no single safe-or-not verdict. pharmaranks gives Rowasa a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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